Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation who have been deemed unsuitable for oral anticoagulation (lilac-timi 76)

Conditions: Atrial Fibrillation (AF)

Summary: a study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (se) in patients with atrial fibrillation (af) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.


Eligibility criteria:
inclusion criteria: * patient is able to understand and has provided written informed consent to participate in the trial * diagnosed atrial fibrillation (af) or atrial flutter (documented on an electrocardiogram (ecg) or monitor recording) * age 65-74 and a cha2ds2vasc ≥4 or age ≥75 and a cha2ds2vasc ≥3 * patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation and this determination was made prior to and independent of the study * at least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (nsaid) use, frailty or multiple falls * patient is judged by the responsible physician to be unsuitable for left atrial appendage (laa) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure and this determination was made prior to and independent of the study exclusion criteria: * af due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (pe), untreated hyperthyroidism, alcohol use) * patients who within 60 days prior to randomization (1) received a vitamin k antagonists (vka) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (doac) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with af * patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment * any stroke within 14 days before randomization or transient ischemic attack (tia) within 3 days before randomization * mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study * patients on dialysis at screening or who are planned to start dialysis within 6 months other protocol defined inclusion/exclusion criteria may apply

Keywords: abelacimab randomized placebo-controlled double-blind endpoint evaluation atrial fibrillation
efficacy of automated distal vascular anastomosis in coronary surgery: phase ii

Conditions: Coronary Artery Disease

Summary: this evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical intervention. the study is designed to assess the ability to compare the patency of grafts created using an automated device versus hand-sewn grafts of the same vessels in the same patient population.

evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the left internal mammary artery and left anterior descending artery among patients with coronary artery disease requiring surgical revascularization.

Eligibility criteria:
inclusion criteria: * age between 50 and 85 years (inclusive) * diagnostically confirmed coronary disease * ejection fraction \> 30% * tolerate contrast media * acceptable lima (conduit) and lad (target)for grafting * life expectancy \> 1 year exclusion criteria: * refusal to give informed consent * unable to meet study travel and general health requirements * pregnancy * previous cardiac surgery * nyha class iv * preoperative need for iabp * acute or chronic dialysis (creatinine \> 200mmolor 2.3 mg/dl) within 30 days of surgery * acute or suspected systemic infection * need for ongoing immunosuppressive therapy * recent history (\<2 weeks) of cva * aspirin allergy

Keywords: cabg, anastomotic device; myocardial revascularization
quality of life study in patients with cancer breakthrough pain treated in palliative care units

Conditions: Breakthrough Pain

Summary: patients treated in palliative care units are potentially fragile patients, especially in our case, which are cancer patients. the management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial. there is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units according to routine clinical practice. for this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain treated in palliative care units as well as the characteristics of these patients. this post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in palliative care units in spanish hospitals.


Eligibility criteria:
inclusion criteria: * patients \> 18 years * patients with advanced cancer * patients attended in palliative care units * life expectancy\> 3 months * written informed consent * patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by davies algorithm exclusion criteria: * serious psychiatric disorder, cognitive impairment or any disease or condition that prevents the collection of data * patients with evidence of opioid addiction or history of drug or alcohol abuse

Keywords: breakthrough cancer pain quality of life palliative care units
phase 2 study of nx9 for delineation of bowel anatomy

Conditions: GI Carcinoma; GI Disorders

Summary: this study will evaluate marking and distention of the bowel of the oral contrast agent, nx9, at ct of the abdomen and pelvis, vldct with no contrast will be followed by vldct with nx9 contrast followed by ct with nx9 and standard iv contrast. eligible subjects will have cancer or other gi disorders for which ct is typically used to assess their disease. this is an open label study with efficacy evaluated in a masked fashion following completion of the entire study. results of the nx9 scans will not be used for treatment decisions. pk will be evaluated in a subset of subjects at a single center.


Eligibility criteria:
inclusion criteria: 1. understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures 2. subject is between the ages of 18 to 85 years old, inclusive 3. has had ct of the abdomen and pelvis with iv contrast within 6 months 4. has a concern for disease involvement of the bowel or structure adjacent to bowel (e.g. peritoneal disease, carcinomatosis, omental cake, bowel inflammation, lymphadenopathy, or fluid collection). 5. is willing and able to comply with protocol-specified ct scanning and visits to the clinic 6. is able to lie flat with arms above head for 15 minutes and hold breath for 15 seconds 7. is able to drink 1.2 liters of fluid within 45 minutes 8. has good venous access as determined by the investigator at screening 9. is an outpatient who is able and willing to come to the clinic for study visits exclusion criteria: 1. has any co-morbidity that the investigator judges will interfere with their ability to complete the study or undergo a quality ct scan, e.g. high risk of aspiration 2. has a history of or is currently suffering from a known gastrointestinal motility disorder, e.g. severe constipation / gastroparesis, achalasia, pseudo-obstruction, etc. 3. has symptoms of a possible current bowel obstruction 4. has a moderate to high risk of current bowel perforation 5. subject should not schedule a gi diagnostic surgery or hospitalization for any procedure until after the study follow-up on day 14 day. however, if at the time of study entry, the subject has pre-planned a surgery or hospitalization, it may be allowed at the discretion of the pi provided it does not take place until after the subject completes the day 3 visit. 6. has a contraindication (i.e. allergy) to iv or oral ct contrast 7. if of child-bearing potential, has a confirmed pregnancy or a high probability of pregnancy at the time of screening 8. has received an investigational therapeutic or diagnostic agent or been treated with an investigational device within the 30 days prior to enrollment.
evaluation of m118 in percutaneous coronary intervention (eminence)

Conditions: Coronary Artery Disease (CAD)

Summary: the primary objective is to evaluate the safety and feasibility of using m118 as an anticoagulant in the target population of subjects with stable coronary artery disease (cad) undergoing percutaneous coronary intervention (pci). the secondary objectives are to evaluate the effect of m118 on procedural indices including procedure success, abrupt closure, post-procedure timi flow, and catheter thrombus. substudy primary objective the primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of m118 among subjects with stable coronary artery disease undergoing elective pci.


Eligibility criteria:
inclusion criteria: * age \> 19 years * ability to give informed consent * documented stable cad with a significant lesion in a native coronary artery amenable to pci with one stent * planned single vessel intervention exclusion criteria: * myocardial infarction or unstable angina within the prior 7 days * target lesion is a chronic total occlusion (present for longer than 3 months) * target lesion with angiographically visible thrombus or in-stent thrombosis * target lesion is in a bypass graft * planned use of a gp iib/iiia inhibitor or planned use of atherectomy including directional, rotational, or laser * known allergies or sensitivities to heparin, pork, or pork-containing products * history of hit * hemodynamic instability * stroke or transient ischemic attack (tia) in the prior 3 months * active bleeding or bleeding diathesis * trauma or major surgery in the preceding month or planned surgery or pci within the 30 days after the index pci * suspected aortic dissection * receiving oral anticoagulation therapy * receipt of lmwh or of ufh (except for that used during the diagnostic portion of the index procedure) within the prior 7 days * act \> 200 prior to study drug administration * severe, untreated hypertension at the time of the index pci procedure (systolic blood pressure of \> 180 mm hg, diastolic blood pressure \> 90 mm hg) * hemoglobin level of less than 10.0 g/dl or a hematocrit below 30% * platelet count of less than 100,000 per cubic millimeter or more than 600,000 per cubic millimeter * creatinine clearance \< 30 ml/min * any malignancy within the prior 5 years with the exception of non-melanoma skin cancers * prior enrollment in eminence trial or currently receiving other experimental therapy * pregnant or lactating if subject is female substudy: inclusion: * ability to give informed consent * participation in the main study protocol exclusion: -inability to provide the blood specimens required by the substudy protocol

Keywords: percutaneous coronary intervention (pci)
mobile app for heart failure

Conditions: Heart Failure

Summary: the investigators developed a mobile health platform to self-management in hf. the aim of this study is to evaluate whether this smartphone app-based intervention can improve symptoms of hf when compared to usual care in hf patients.


Eligibility criteria:
inclusion criteria: * patients aged 20 years or older hospitalized for acute heart failure. * patients who have obvious symptoms or sign of hf at admission * n-terminal prohormone of brain natriuretic peptide (nt-probnp) ≥400 pg/ml or brain natriuretic peptide (bnp) ≥100 pg/ml. * participants should be able to use smartphone well. exclusion criteria: * patients who have baseline systolic blood pressure \<90 mmhg or resting heart rate \<50 beats per minutes * patients who cannot use smartphone * patients who had cardiac implantable electronic device will be excluded
the genetics of chiari type i malformation

Conditions: Chiari Type I Malformation

Summary: duke university medical center is investigating the hereditary basis of chiari type i malformations with or without syringomyelia (cm1/s). our research is aimed at learning if cm1/s is indeed caused by factors inherited through the family and, if so, which genes are involved.


Eligibility criteria:
the study is not currently enrolling new participants.

Keywords: chiari chiari type i chiari type i malformation familial chiari
effect of deep propioceptive stimulation in prader-willi syndrome

Conditions: Sleep Disorder; Hyperphagia; Behavior Disorders

Summary: the main objective is to study the effect of deep propioceptive stimulation with a heavy blanket for 2 weeks compared with a placebo blanket on sleep quality and behavior in patients with pws

prader-willi syndrome (pws) is a genetic disease associated with sleep disorders whose etiology is partly central due to the inherent hypothalamic deficit. it is associated with low cognitive performance and worsening behavior with more impulsivity, tantrums, scratches and obsession for food. deep propioceptive stimulation with a heavy blanket (hb) stimulates the parasympathetic system and improves the state of anxiety in persons with autism or other causes of intellectual disability and/or psychopathology. to date, there are no studies evaluating the effect of hb on sleep quality or brain activity in persons with pws. the main objective is to study the effect of hb for 2 weeks compared to a placebo blanket on sleep quality and behavior in patients with spw. methodology: actigraphy, questionnaires, crossover study in 60 patients with pws, with hb/placebo blankets (15 days each). effect of hb on brain connectivity with functional magnetic resonance imaging in 30 patients and 30 controls. expected results: pws group will show worse sleep quality and behavior that will improve after using hb. brain connectivity will be different with/without hb. these favorable changes will help to justify the use of this ecological treatment and its inclusion in the nhs clinical practice guidelines for improving the quality of life of these patients and their caregivers.

Eligibility criteria:
inclusion criteria: * patients with pws genetically confirmed at least 16y old willing to participate and being able to be still in the mri. exclusion criteria: 1. age \< 16 years old 2. presence of uncontrolled obstructive sleep apnea (residual ahi ≥ 30). 3. narcolepsy or other sleep disorders with daily somnolence 4. intolerance to the heavy blanket in spite of previous adaptation sessions 5. active psychopathological disorder that may interfere with sleep 6. use of hypnotic or sleep regulator drugs (change of dose in the last 3 months) 7. contraindications for mri 8. impossibility to stay still during mri adquisition
biodegradable versus titanium nailing in forearm shaft fractures in children

Conditions: Forearm Fracture

Summary: there are disadvantages in elastic stable intramedullary nailing (esin) of forearm shaft fractures, such as soft tissue irritation and the need of implant removal. a new mini-invasive technique of intramedullary nailing with biodegradable material (besin) has been developed. the nails are tapped into the medullary cavity and left in place. the aim of this study was to compare besin technique with esin. this is a prospective, randomized, controlled clinical trial including the patients (aged 5-15 years) who required operative treatment for forearm shaft fractures in two pediatric trauma centers, in finland. the patients were randomized to be treated by besin or esin. thirteen patients were required for each group, according to power analysis but altogether 35 were enrolled for potential drop-outs. biodegradable polylactide-co-glycolide (plga) nails (activanail ®, bioretec ltd, finland) were used in 19 and titanium nails (ten ®, synthes ltd, usa) in 16 patients. pain and the range of motion (rom) of forearm, elbow and wrist were primary outcomes. radiographs and potential complications were analyzed of all and magnetic resonance imagines (mri) of a randomly selected subgroup in besin group (n=13).


Eligibility criteria:
inclusion criteria: * suffering from single- or both-bone forearm shaft fracture * child patient , age from 5 to 15 years * surgical fixation needed, fracture is unstable * cast immobilization is not rigid enough for the fracture treatment exclusion criteria: * open fractures with significant soft-tissue injury * pathological fractures * if patient has a previous fracture or infection in the same forearm * patients with metabolic bone diseases, systematic disease * patient uses the medication affecting bone quality * resistance to infection * fractures older than 7 days

Keywords: intramedullary nailing randomised controlled trial biodegradable children forearm shaft fractures
chronic pain and vitamin d

Conditions: Chronic Musculoskeletal Pain; Vitamin D Supplementation

Summary: non-systematized chronic musculoskeletal pains are a frequent reason for consulting in general practice. the possible causes are numerous and sometimes nonspecific. in some cases, the etiologic investigation of patients with non-systematized and chronic musculoskeletal pain can not highlight any organic cause. several studies have shown a link between these symptoms and vitamin d deficiency, characterized by a blood level of 25 (oh) vitamin d \< 20.8ng/ml. this deficit is easy to identify and to correct through proper vitamin d supplementation with few side effects. nevertheless, it remains unknown and vitamin d deficiency is rarely considered as a possible etiology in patients with chronic pain. we hypothesize that vitamin d supplementation in patients with non-systematized musculoskeletal pain and deficient in vitamin d could improve painful symptoms. we aim to perform a double-blind randomized controlled trial, vitamin d versus placebo, to assess the pain improvement after vitamin d supplementation.


Eligibility criteria:
inclusion criteria: * women and men * aged 18-50 years (included) * consulting their general practitioner * with chronic and diffuse musculoskeletal pain, without known etiology, lasting for at least 3 months * with a 25(oh)vitamin d deficiency \<20.8 ng/ml (52 nmol/l) at inclusion * who signed the consent form exclusion criteria: * identifiable source of pain requiring an appropriate specific management * disease or treatment that may interfere with the metabolism of vitamin d * current or previous hypercalcemia or hypercalciuria, treatment with digitalics and patients with history of nephrolithiasis * current treatment with vitamin d or at least one vitamin d vial taken over the previous 6 months * pregnancy or breastfeeding * not affiliated to a social security system * refusal or inability to give consent

Keywords: vitamin d deficiency musculoskeletal pain vitamin d supplementation
maxillary expansion effects in children with upper airway obstruction

Conditions: Airway Obstruction

Summary: the most frequent causes of mouth breathers are the adenotonsillar hypertrophy. adenotonsillectomy is the main choice for the elimination of the obstruction. however, this surgical treatment does not have its effect well elucidated and apnea has been cited in the literature as a residual outcome. other types of supporting treatment may also been involved such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among them rapid maxillary expansion (rme). rme corrects the morphological constriction of the upper arch caused by buccal breathing and also reduce the airway resistance. despite reports of rme influencing volume enhancement in pharyngeal airway, there are still few three-dimensional studies following the post-expansion effects. in addition, these changes are doubtful due postural changes of the tongue during the tomography exam. conflicts of results are also present for changes in the nasal septum of children. the main alteration mentioned is the increase in the length of the lower third of the septum. the investigators propose a randomized, prospective, controlled clinical trial in patients with atresic maxilla with or without adenotonsillar hypertrophy. the patients will be treated with rme and adenotonsillectomy when the obstruction is present. the purpose of this study is elucidate if there is different outcomes considering the moment of rme treatment before or after the adenotonsillectomy.


Eligibility criteria:
inclusion criteria: * children (boys and girls) between 5 and 9 years of age. * atresic maxilla. * skeletal class i * with or without adenotonsillar hypertrophy * parents or tutors sign informed consent. exclusion criteria: * craniofacial syndromes or neurologic disease diagnosis. * history of adenotonsillectomy and orthodontic treatment * history of facial trauma * morbid obesity * premature loss of posterior teeth

Keywords: maxillary expansion adenotonsillar hypertrophy airway volume